ARSENIC TRIOXIDE

N/A

Manufactured by Cephalon, LLC

4,344 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ARSENIC TRIOXIDE

ARSENIC TRIOXIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Cephalon, LLC. The most commonly reported adverse reactions for ARSENIC TRIOXIDE include ELECTROCARDIOGRAM QT PROLONGED, DIFFERENTIATION SYNDROME, OFF LABEL USE, PYREXIA, PNEUMONIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ARSENIC TRIOXIDE.

Top Adverse Reactions

ELECTROCARDIOGRAM QT PROLONGED256 reports
DIFFERENTIATION SYNDROME210 reports
OFF LABEL USE160 reports
PYREXIA108 reports
PNEUMONIA82 reports
ALANINE AMINOTRANSFERASE INCREASED79 reports
FEBRILE NEUTROPENIA78 reports
DYSPNOEA77 reports
PLEURAL EFFUSION74 reports
DRUG INEFFECTIVE73 reports
NEUTROPENIA72 reports
WHITE BLOOD CELL COUNT DECREASED72 reports
NAUSEA69 reports
ACUTE PROMYELOCYTIC LEUKAEMIA DIFFERENTIATION SYNDROME67 reports
ANAEMIA65 reports
ASPARTATE AMINOTRANSFERASE INCREASED65 reports
DIARRHOEA62 reports
HYPOTENSION62 reports
FATIGUE61 reports
HYPOKALAEMIA60 reports
PANCYTOPENIA59 reports
PERICARDIAL EFFUSION58 reports
THROMBOCYTOPENIA55 reports
VOMITING55 reports
PLATELET COUNT DECREASED50 reports
SEPSIS50 reports
DISSEMINATED INTRAVASCULAR COAGULATION49 reports
RESPIRATORY FAILURE48 reports
WHITE BLOOD CELL COUNT INCREASED48 reports
HYPERLEUKOCYTOSIS47 reports
ACUTE KIDNEY INJURY46 reports
HEPATIC FUNCTION ABNORMAL46 reports
LEUKOCYTOSIS46 reports
NEUROPATHY PERIPHERAL46 reports
DISEASE PROGRESSION45 reports
HAEMOGLOBIN DECREASED45 reports
IDIOPATHIC INTRACRANIAL HYPERTENSION45 reports
HEADACHE44 reports
ASTHENIA42 reports
WEIGHT INCREASED42 reports
CONFUSIONAL STATE39 reports
RASH39 reports
RENAL FAILURE39 reports
DEATH37 reports
LEUKAEMIA RECURRENT37 reports
PERICARDITIS37 reports
ACUTE MYELOID LEUKAEMIA33 reports
GAMMA GLUTAMYLTRANSFERASE INCREASED33 reports
TACHYCARDIA32 reports
CHEST PAIN31 reports
CONDITION AGGRAVATED31 reports
HYPOXIA30 reports
MALIGNANT NEOPLASM PROGRESSION30 reports
MUCOSAL INFLAMMATION30 reports
BLOOD ALKALINE PHOSPHATASE INCREASED29 reports
PRODUCT USE IN UNAPPROVED INDICATION29 reports
CHILLS28 reports
DRUG INTERACTION28 reports
INFECTION28 reports
RENAL FAILURE ACUTE28 reports
ABDOMINAL PAIN27 reports
ACUTE PROMYELOCYTIC LEUKAEMIA27 reports
FALL27 reports
HEPATOTOXICITY27 reports
BACK PAIN26 reports
LEUKOPENIA26 reports
HYPOMAGNESAEMIA25 reports
BLOOD LACTATE DEHYDROGENASE INCREASED24 reports
MALAISE24 reports
ATRIAL FIBRILLATION23 reports
BLOOD CREATININE INCREASED23 reports
COUGH23 reports
DEHYDRATION23 reports
HERPES ZOSTER23 reports
PARAESTHESIA23 reports
PULMONARY OEDEMA23 reports
CARDIAC FAILURE22 reports
ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED22 reports
HYPERGLYCAEMIA22 reports
INTENTIONAL PRODUCT USE ISSUE22 reports
INTRACRANIAL PRESSURE INCREASED22 reports
MYELODYSPLASTIC SYNDROME TRANSFORMATION22 reports
RETINOIC ACID SYNDROME22 reports
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS21 reports
NEUROTOXICITY21 reports
NEUTROPHIL COUNT DECREASED21 reports
ARTHRALGIA20 reports
CARDIAC ARREST20 reports
CARDIAC FAILURE CONGESTIVE20 reports
RESPIRATORY DISTRESS20 reports
STAPHYLOCOCCAL INFECTION20 reports
VENTRICULAR TACHYCARDIA20 reports
CEREBRAL HAEMORRHAGE19 reports
DECREASED APPETITE19 reports
URTICARIA19 reports
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED18 reports
ACUTE RESPIRATORY DISTRESS SYNDROME18 reports
C REACTIVE PROTEIN INCREASED18 reports
LYMPHOPENIA18 reports
PAIN18 reports

Report Outcomes

Out of 2,218 classified reports for ARSENIC TRIOXIDE:

Serious 95.6%Non-Serious 4.4%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male939 (50.5%)
Female907 (48.7%)
Unknown15 (0.8%)

Reports by Age

Age 6053 reports
Age 6549 reports
Age 7647 reports
Age 4042 reports
Age 7242 reports
Age 7340 reports
Age 7036 reports
Age 6935 reports
Age 3932 reports
Age 6132 reports
Age 3631 reports
Age 6331 reports
Age 7531 reports
Age 5930 reports
Age 5328 reports
Age 6228 reports
Age 7428 reports
Age 6727 reports
Age 5226 reports
Age 5725 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with ARSENIC TRIOXIDE?

This profile reflects 4,344 FDA FAERS reports that mention ARSENIC TRIOXIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ARSENIC TRIOXIDE?

Frequently reported terms in FAERS include ELECTROCARDIOGRAM QT PROLONGED, DIFFERENTIATION SYNDROME, OFF LABEL USE, PYREXIA, PNEUMONIA, ALANINE AMINOTRANSFERASE INCREASED. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ARSENIC TRIOXIDE?

Labeling and FAERS entries often list Cephalon, LLC in connection with ARSENIC TRIOXIDE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.